Army finds simple blood test to identify mild brain trauma
FREDERICK, Md. - The Army says it has discovered a simple blood test that can diagnose mild traumatic brain damage or concussion, a hard-to-detect injury that can affect young athletes, infants with "shaken baby syndrome" and combat troops.
"This is huge," said Gen. Peter Chiarelli, the Army vice chief of staff.
Army Col. Dallas Hack, who has oversight of the research, says recent data show the blood test, which looks for unique proteins that spill into the blood stream from damaged brain cells, accurately diagnosing mild traumatic brain injury in 34 patients.
Doctors can miss these injuries because the damage does not show up on imaging scans, and symptoms such as headaches or dizziness are ignored or downplayed by the victims.
If the brain is not allowed time to recover and a second concussion occurs, permanent damage may result. Brain injuries afflict 1.4 million Americans each year, says the National Brain Injury Association. Seventy percent are mild cases.
About 300,000 troops in Iraq and Afghanistan have suffered concussions, mostly from roadside bombs, according to a RAND Corp. study.
Hack says the new findings could rival the discovery of unique proteins in the 1970s that now help doctors identify heart disease.
"This will in fact do for brain injury what that test did for chest pain. It's going to change medicine entirely," Hack says.
If the Army wins FDA approval for the test, the discovery could be a milestone in brain-injury care, says Gregory O'Shanick, national medical director for the Brain Injury Association of America.
"We will find people who are under the radar and then treat them appropriately," he says.
The Army collaborated on the biomarker program with Florida-based Banyan Biomarkers, company created by former faculty member of the University of Florida.
The company recently received $26 million to conduct a final, large set of clinical trials through 2013 on 1,200 patients suffering mild to moderate to severe brain injuries. The patients will be drawn from 30 trauma centers across the country. The success of this phase will determine FDA approval for public use of the biomarker test, Hack says.
"We're trying to see if we can make that (clinical trial) earlier and make it faster," Hack says.
Physician Jeffrey Bazarian said the results may be flawed if researchers are studying only people admitted into hospitals. Their brain injuries, even if characterized as mild, may be more severe than common forms of concussion.
"The key is whatever patients they study need to look like concussed patients, walking, talking and not necessarily in need of hospitalization," said Bazarian, a trauma specialist who has served on task forces involving brain injury and panels for the CDC. "If you just look at the milds that are admitted ... that's potentially a flaw."
Area biotech company Banyan Biomarkers on cutting edge
Banyan Biomarker's brain injury work put it on the map.
Published: Sunday, October 17, 2010 at 4:33 p.m.
Last Modified: Sunday, October 17, 2010 at 11:05 p.m.
The founders of Banyan Biomarkers describe the Alachua-based research firm as a "Gator-made company."
* Founded in 2002
* Based at Progress Corporate Park in Alachua
* 58 employees housed in 20,000 square feet
* Recently received a $26.3 million contract to develop a diagnostic blood test for traumatic brain injury
* Developing biomarkers for stroke, neurodegenerative diseases, neurological and psychiatric disorders and more
Banyan made news recently when it was awarded a $26.3 million Department of Defense contract to develop a diagnostic blood test for traumatic brain injury, or TBI. The company has been studying "biomarkers," or proteins in the blood produced by an injured brain.
An estimated 1.4 million people annually suffer a traumatic brain injury in the U.S., resulting in more than 230,000 hospitalizations, 50,000 deaths, and 80,000 to 90,000 people left permanently disabled. Currently, 5.3 million Americans live with TBI-related disabilities, compared with 4 million who are disabled by Alzheimer's disease.
In the military, it is estimated that up to 20 percent of combat veterans have suffered some degree of traumatic brain injury due to bomb blasts while in Iraq or Afghanistan.
Banyan's blood test, which looks for unique proteins that spill into the blood stream from damaged brain cells, has put the company on the biotech map. But what really excites Banyan executives Ron Hayes, Kevin Wang and Jackson Streeter are potential products also in the research pipeline at the company's Center of Innovative Research, or CoIR.
Hayes and Wang left faculty positions at the University of Florida to spin off Banyan in 2002. Banyan's CoIR promotes basic and applied human disease research that is focused on brain disorders, but it also includes other organ systems such as liver damage. CoIR investigators have landed 16 grants from the National Institutes of Health and the Department of Defense.
Streeter joined the company in February as CEO and chief medical officer, relocating from San Diego.
Hayes says Banyan was founded to address two systemic failures, within universities and "big pharma."
The universities do a good job at discovery in small laboratories run by dedicated investigators, Hayes explained. Where they fall short is in trying to commercialize their discoveries readily. Large pharmaceutical companies, he said, have learned that it is impossible to manage discovery.
"Now, they go ahead and buy discovery where they can find it," Hayes explained. "You can't manage genius, but you can put it in place."
That was the thinking that led to Banyan and its research institute within the company.
The company's next big test will come with trials of its biomarker for traumatic brain injury. Brain injury diagnosis is currently done through a clinical exam and expensive imaging studies, primarily CT scans that can involve a radiation risk for the patient.
Banyan's simple point-of-care blood test can be administered on the battlefield or the site of a roadside crash to detect whether a patient has a brain injury. "When we achieve that, it is a huge breakthrough," Streeter said. "It will prevent unnecessary CT scans and lead to more rapid diagnosis of patients who urgently need treatment for a brain injury."
With Department of Defense funding, Banyan's TBI biomarker will be tested beginning next year on 1,200 patients selected at 30 centers, 10 of them in the United States. Streeter says one center will be the University of Florida, with others will be in Ocala, Tampa, Jacksonville and potentially Tallahassee.
If the U.S. Food and Drug Administration approves the biomarker test, it could be on the market by 2013.
The discovery could be a milestone in brain-injury care, according to Gregory O'Shanick, national medical director for the Brain Injury Association of America.
"We will find people who are under the radar and then treat them appropriately," he said.
"So many biotech companies are 'one trick ponies' that live or die based on one single product," Wang said. "Very early on, we wanted to diversify what we were working on."
The firm is complementing its diagnostics development by offering a range of core biomarkers for research applications along with service offerings based on its panel of neurological, psychiatric, neurodegenerative disease, and organ toxicity biomarker assays. Additional analytical services use the firm's animal models and primary neuronal culture models of neuroinjury or neurotoxicity. Nanoparticle researchers are looking at ways to package drugs for delivery to the nerve cells.
Others are working on stem-cell research, collaborating with colleagues at the Chinese University of Hong Kong, looking at stem cells extracted from adipose (fat) tissue. The company also is creating a neuro-proteomics center that will support the TBI studies and enable researchers to look at other neurodegenerative diseases.
Chronic traumatic encephalopathy, or CTE, has increasingly been identified in boxers and pro football players who have suffered numerous concussions, Wang said.
"How many of our high school and college athletes will be impacted by this in their lifetime?" he asked.
There is no blood test for early diagnosis of Alzheimer's disease or CTE, just examination of the spinal fluid, which is a very invasive test, Wang said.
"Most companies have a restricted repertoire," Hayes said. "What separates Banyan as a biotechnology company is the richness of our pipeline."